WO2005102271A3 - Pharmaceutical compositions for glucocorticoid replacement therapy - Google Patents

Pharmaceutical compositions for glucocorticoid replacement therapy Download PDF

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Publication number
WO2005102271A3
WO2005102271A3 PCT/EP2005/004400 EP2005004400W WO2005102271A3 WO 2005102271 A3 WO2005102271 A3 WO 2005102271A3 EP 2005004400 W EP2005004400 W EP 2005004400W WO 2005102271 A3 WO2005102271 A3 WO 2005102271A3
Authority
WO
WIPO (PCT)
Prior art keywords
glucocorticoids
glucocorticoid
relates
component
designed
Prior art date
Application number
PCT/EP2005/004400
Other languages
French (fr)
Other versions
WO2005102271A2 (en
Inventor
Stanko Skrtic
Joergen Johnsson
Hans Lennernaes
Thomas Hedner
Gudmundur Johannsson
Original Assignee
Duocort Ab
Stanko Skrtic
Joergen Johnsson
Hans Lennernaes
Thomas Hedner
Gudmundur Johannsson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US11/587,514 priority Critical patent/US8425937B2/en
Priority to EP16169413.8A priority patent/EP3072507B1/en
Priority to AU2005235370A priority patent/AU2005235370B2/en
Priority to MXPA06012011A priority patent/MXPA06012011A/en
Priority to CN2005800118623A priority patent/CN1942176B/en
Priority to RS20160749A priority patent/RS55198B1/en
Priority to LTEP05735076.1T priority patent/LT1744730T/en
Priority to BRPI0510044A priority patent/BRPI0510044B8/en
Priority to PL16169413T priority patent/PL3072507T3/en
Priority to MX2013004889A priority patent/MX344197B/en
Priority to CA2564000A priority patent/CA2564000C/en
Priority to JP2007508863A priority patent/JP5149618B2/en
Application filed by Duocort Ab, Stanko Skrtic, Joergen Johnsson, Hans Lennernaes, Thomas Hedner, Gudmundur Johannsson filed Critical Duocort Ab
Priority to EP05735076.1A priority patent/EP1744730B1/en
Priority to ES05735076.1T priority patent/ES2600556T3/en
Priority to DK05735076.1T priority patent/DK1744730T3/en
Priority to MEP-2016-250A priority patent/ME02584B/en
Publication of WO2005102271A2 publication Critical patent/WO2005102271A2/en
Publication of WO2005102271A3 publication Critical patent/WO2005102271A3/en
Priority to IL178776A priority patent/IL178776A/en
Priority to US13/722,013 priority patent/US20130129823A1/en
Priority to IL227375A priority patent/IL227375A/en
Priority to US14/255,332 priority patent/US10583146B2/en
Priority to HRP20161380TT priority patent/HRP20161380T1/en
Priority to CY20161101091T priority patent/CY1118275T1/en
Priority to CY20211100191T priority patent/CY1124074T1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/42—Drugs for disorders of the endocrine system of the suprarenal hormones for decreasing, blocking or antagonising the activity of mineralocorticosteroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/44—Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers

Abstract

The invention relates to glucocorticoid replacement therapy and provides pharmaceutical compositions and kits designed to deliver one or more glucocorticoids to a subject in need thereof in a manner that results in serum levels of the glucocorticoid that essentially mimic that of a healthy subject for a clinically relevant period of time. The pharmaceutical composition comprises one or more glucocorticoids, wherein a first part of one or more glucocorticoids is substantially immediately released and a second part of one or more glucocorticoids is released over an extended period of time of at least about 8 hours, and the amount of the one or more glucocorticoids of the first part, expressed as hydrocortisone equivalents, is in a range of from about 15 to about 50% of the total hydrocortisone equivalents. The invention also relates to a kit comprising a first and a second component, the first component designed to release one or more glucocorticoids substantially immediately and the second component is designed to release one or more glucocorticoids over an extended period of time of at least 8 hours. The invention also relates to a method for treating diseases requiring glucocorticoid treatment such as in subjects having a glucocorticoid deficiency disorder. In another aspect the invention relates to the use of a first and a second amount of one or more glucocorticoids for the preparation of a pharmaceutical composition or kit for the treatment of a glucocorticoid deficiency disorder.
PCT/EP2005/004400 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy WO2005102271A2 (en)

Priority Applications (23)

Application Number Priority Date Filing Date Title
EP05735076.1A EP1744730B1 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
EP16169413.8A EP3072507B1 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
ES05735076.1T ES2600556T3 (en) 2004-04-22 2005-04-21 Replacement of pharmaceutical compositions for glucocorticoid therapy
CN2005800118623A CN1942176B (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
RS20160749A RS55198B1 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
LTEP05735076.1T LT1744730T (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
BRPI0510044A BRPI0510044B8 (en) 2004-04-22 2005-04-21 pharmaceutical composition, and, use of a pharmaceutical composition
PL16169413T PL3072507T3 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
MX2013004889A MX344197B (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy.
CA2564000A CA2564000C (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
JP2007508863A JP5149618B2 (en) 2004-04-22 2005-04-21 Pharmaceutical composition for glucocorticoid replacement therapy
US11/587,514 US8425937B2 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
AU2005235370A AU2005235370B2 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
MXPA06012011A MXPA06012011A (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy.
DK05735076.1T DK1744730T3 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
MEP-2016-250A ME02584B (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
IL178776A IL178776A (en) 2004-04-22 2006-10-19 Coated tablet dosage form for delivery of glucocorticoid replacement therapy
US13/722,013 US20130129823A1 (en) 2004-04-22 2012-12-20 Pharmaceutical compositions for glucocorticoid replacement therapy
IL227375A IL227375A (en) 2004-04-22 2013-07-08 Coated tablet dosage form for delivery of glucocorticoid replacement therapy
US14/255,332 US10583146B2 (en) 2004-04-22 2014-04-17 Pharmaceutical compositions for glucocorticoid replacement therapy
HRP20161380TT HRP20161380T1 (en) 2004-04-22 2016-10-24 Pharmaceutical compositions for glucocorticoid replacement therapy
CY20161101091T CY1118275T1 (en) 2004-04-22 2016-10-26 PHARMACEUTICAL COMPOSITIONS FOR GLYCOCORDIC REPLACEMENT THERAPY
CY20211100191T CY1124074T1 (en) 2004-04-22 2021-03-05 PHARMACEUTICAL COMPOSITIONS FOR GLUCOCORTICO REPLACEMENT THERAPY

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US56420504P 2004-04-22 2004-04-22
SE0401031-0 2004-04-22
US60/564,205 2004-04-22
SE0401031A SE0401031D0 (en) 2004-04-22 2004-04-22 A new glucocorticoid replacement therapy

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/722,013 Continuation US20130129823A1 (en) 2004-04-22 2012-12-20 Pharmaceutical compositions for glucocorticoid replacement therapy

Publications (2)

Publication Number Publication Date
WO2005102271A2 WO2005102271A2 (en) 2005-11-03
WO2005102271A3 true WO2005102271A3 (en) 2006-08-03

Family

ID=35197481

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/004400 WO2005102271A2 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy

Country Status (26)

Country Link
US (3) US8425937B2 (en)
EP (2) EP3072507B1 (en)
JP (2) JP5149618B2 (en)
CN (2) CN1942176B (en)
AU (1) AU2005235370B2 (en)
BR (1) BRPI0510044B8 (en)
CA (1) CA2564000C (en)
CY (2) CY1118275T1 (en)
DK (2) DK1744730T3 (en)
ES (2) ES2600556T3 (en)
HK (1) HK1179525A1 (en)
HR (2) HRP20161380T1 (en)
HU (2) HUE053248T2 (en)
IL (2) IL178776A (en)
LT (2) LT1744730T (en)
ME (1) ME02584B (en)
MX (2) MXPA06012011A (en)
NZ (1) NZ585340A (en)
PL (2) PL3072507T3 (en)
PT (2) PT1744730T (en)
RS (2) RS61501B1 (en)
SE (1) SE0401031D0 (en)
SG (1) SG188081A1 (en)
SI (1) SI3072507T1 (en)
WO (1) WO2005102271A2 (en)
ZA (1) ZA200609680B (en)

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CA2563609C (en) * 2004-04-22 2012-11-06 Duocort Ab Pharmaceutical compositions for acute glucocorticoid therapy
SE0401031D0 (en) * 2004-04-22 2004-04-22 Duocort Ab A new glucocorticoid replacement therapy
AU2006322050A1 (en) * 2005-12-06 2007-06-14 Monosol Rx, Llc Topical film compositions for delivery of actives
FR2926722B1 (en) * 2008-01-25 2010-09-03 Substipharm Dev APPROPRIATE PHARMACEUTICAL FORMULATION FOR THE PREPARATION OF ORODISPERSIBLE PRELOISOLONE TABLETS
DE502008002621D1 (en) * 2008-07-21 2011-03-31 Falk Pharma Gmbh Pharmaceutical formulation for the treatment of the upper digestive tract
AU2010234320A1 (en) 2009-04-07 2011-10-27 Duocort Pharma Ab Improved glucocorticoid therapy
AU2011254959A1 (en) * 2010-05-20 2013-01-10 Duocort Pharma Ab Posology and administration of glucocorticoid based compositions
GB201119985D0 (en) * 2011-11-19 2012-01-04 Diurnal Ltd Treatment of adrenal insufficiency
GB201202433D0 (en) 2012-02-13 2012-03-28 Diurnal Ltd Controlled drug release
JP2014086673A (en) 2012-10-26 2014-05-12 Mitsubishi Electric Corp Monolithic integrated circuit
PT2914255T (en) 2012-11-02 2021-10-27 Murray & Poole Entpr Ltd Treatment or prevention of cardiovascular events via the administration of a colchicine derivative
EP2986280B1 (en) 2013-04-16 2021-03-17 Murray & Poole Enterprises, Ltd. Sustained-release formulations of colchicine and methods of using same
GB201308933D0 (en) 2013-05-17 2013-07-03 Diurnal Ltd Paediatric composition
MX348595B (en) * 2013-08-02 2017-06-21 Laboratorio Raam De Sahuayo S A De C V Pharmaceutical composition with anti-inflammatory agents and production process thereof.
DK2886108T4 (en) 2013-12-23 2023-01-30 Dr Falk Pharma Gmbh Optimized pharmaceutical formulation for the treatment of inflammatory changes of the esophagus
AU2016243625B2 (en) 2015-03-30 2020-09-10 Corcept Therapeutics, Inc. Use of glucocorticoid receptor antagonists in combination with glucocorticoids to treat adrenal insufficiency
CN107115308B (en) * 2016-02-23 2021-02-23 天津金耀集团有限公司 Hydrocortisone biphasic sustained-release tablet composition
RU2748437C2 (en) * 2019-10-28 2021-05-25 Федеральное государственное бюджетное учреждение науки Институт цитологии Российской академии наук (ИНЦ РАН) Hydrocortisone derivative for alzheimer's disease treatment
FR3116439B1 (en) * 2020-11-26 2023-08-04 Laboratoire Dielen Film-coated tablet containing at least one active ingredient, suitable for oral administration of said at least one active ingredient in human subjects

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EP0745382A1 (en) * 1994-01-31 1996-12-04 Yamanouchi Pharmaceutical Co. Ltd. Intraorally soluble compressed molding and process for producing the same
WO1998048782A1 (en) * 1997-04-29 1998-11-05 Jenapharm Gmbh & Co. Kg Method for producing orally administered, solid pharmaceutical products with controlled release of the active substance
WO2002072033A2 (en) * 2001-03-13 2002-09-19 Penwest Pharmaceuticals Co. Chronotherapeutic dosage forms containing glucocorticosteroid

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CA2563609C (en) 2004-04-22 2012-11-06 Duocort Ab Pharmaceutical compositions for acute glucocorticoid therapy
SE0401031D0 (en) * 2004-04-22 2004-04-22 Duocort Ab A new glucocorticoid replacement therapy
GB0623740D0 (en) 2006-11-28 2007-01-10 Diurnal Ltd Treatment of disease
AU2010234320A1 (en) 2009-04-07 2011-10-27 Duocort Pharma Ab Improved glucocorticoid therapy
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FR2209585A1 (en) * 1972-12-09 1974-07-05 Hoechst Ag
GB1458676A (en) * 1972-12-09 1976-12-15 Hoechst Ag Orally administrable corticosteroid preparations
WO1992011001A1 (en) * 1990-12-19 1992-07-09 Solvay (Societe Anonyme) Oral pharmaceutical composition
EP0745382A1 (en) * 1994-01-31 1996-12-04 Yamanouchi Pharmaceutical Co. Ltd. Intraorally soluble compressed molding and process for producing the same
WO1998048782A1 (en) * 1997-04-29 1998-11-05 Jenapharm Gmbh & Co. Kg Method for producing orally administered, solid pharmaceutical products with controlled release of the active substance
WO2002072033A2 (en) * 2001-03-13 2002-09-19 Penwest Pharmaceuticals Co. Chronotherapeutic dosage forms containing glucocorticosteroid

Also Published As

Publication number Publication date
MX344197B (en) 2016-12-08
BRPI0510044B8 (en) 2021-05-25
BRPI0510044B1 (en) 2019-01-29
ME02584B (en) 2017-06-20
US10583146B2 (en) 2020-03-10
CY1118275T1 (en) 2017-06-28
HRP20161380T1 (en) 2016-12-02
IL178776A (en) 2013-10-31
PL1744730T3 (en) 2017-01-31
EP1744730A2 (en) 2007-01-24
EP3072507A1 (en) 2016-09-28
HUE053248T2 (en) 2021-06-28
HRP20210348T1 (en) 2021-04-16
BRPI0510044A (en) 2007-10-16
HK1179525A1 (en) 2013-10-04
PT1744730T (en) 2016-10-07
ES2600556T3 (en) 2017-02-09
DK1744730T3 (en) 2016-08-29
EP1744730B1 (en) 2016-08-03
ES2857600T3 (en) 2021-09-29
IL227375A (en) 2017-08-31
US20080187586A1 (en) 2008-08-07
SG188081A1 (en) 2013-03-28
EP3072507B1 (en) 2020-12-23
DK3072507T3 (en) 2021-02-08
JP2012236846A (en) 2012-12-06
LT3072507T (en) 2021-02-25
CN103006592B (en) 2016-03-02
MXPA06012011A (en) 2007-04-16
CY1124074T1 (en) 2022-03-24
CN1942176A (en) 2007-04-04
RS61501B1 (en) 2021-03-31
CN103006592A (en) 2013-04-03
US8425937B2 (en) 2013-04-23
CN1942176B (en) 2013-09-18
SI3072507T1 (en) 2021-04-30
NZ585340A (en) 2012-04-27
JP5149618B2 (en) 2013-02-20
RS55198B1 (en) 2017-01-31
US20140242167A1 (en) 2014-08-28
IL178776A0 (en) 2007-02-11
CA2564000A1 (en) 2005-11-03
ZA200609680B (en) 2008-08-27
PL3072507T3 (en) 2021-07-19
HUE030546T2 (en) 2017-05-29
SE0401031D0 (en) 2004-04-22
LT1744730T (en) 2016-10-25
AU2005235370A1 (en) 2005-11-03
CA2564000C (en) 2013-07-02
JP2007533698A (en) 2007-11-22
JP5681679B2 (en) 2015-03-11
WO2005102271A2 (en) 2005-11-03
PT3072507T (en) 2021-02-23
US20130129823A1 (en) 2013-05-23
AU2005235370B2 (en) 2011-06-09

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